The Recall Desk
ModerateFDA (Devices)·Z-1422-2015·Announced 2015-04-22

Nobel Biocare Recalls Dental Implants Due to Packaging Material Contamination

Nobel Biocare is recalling 72 dental implants because packaging material may leave a sticky substance on the implant surfaces and threads.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a packaging material defect that may leave a sticky substance on the device. No injuries or illnesses are reported, and the defect is limited to surface contamination rather than a structural failure or high-risk pathogen.

Plain-English summary

Nobel Biocare USA LLC is recalling 72 units of NobRpl Tapered Groovy 6.0mm 6x11.5mm dental implants (Article No. 36103, Batch No. 113010001). The recall was initiated because a material used in the packaging of the devices may impart a sticky substance on the top surfaces of the implants and, in some cases, on the first threads.

The affected dental implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices. The recall covers units distributed nationwide in the United States and internationally to numerous countries, including Austria, Australia, Belgium, Canada, Germany, France, and the United Kingdom.

Consumers and healthcare providers who have these specific implants should contact Nobel Biocare USA LLC for instructions on how to return the product or obtain a replacement. The source text does not report any specific injuries or illnesses associated with this recall.

The recalled product

Product
NobRpl Tapered Groovy 6.0mm 6x11.5mm, Article No. 36103. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in ord
Manufacturer
Nobel Biocare Usa Llc
Category
Medical Device — Dental Implants
Hazard
Affected units
72

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Batch No. 113010001.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 27 recalled by Nobel Biocare Usa Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 27 products in this recall →

Related recalls

Same manufacturer · Nobel Biocare Usa Llc

See all →

Same hazard · packaging contamination

See all →